Online Course Teachning Adults With ADHD How to Use a Smartphone (VardagsSMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01663610
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):
Viktor Kaldo, Karolinska Institutet

Brief Summary:
This study is a randomized controlled trial (RCT) to evaluate the effect of an internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis or struggle with organizing daily life and/or easily get distracted. The course (vardagsSMART) teach the participants how to use a Smartphone to better organize their everday life and will be compared to a wait list control group (CONT) that later will recieve the same course without guidance from a supervisor(selfSMART). It is hypothesized that VardagsSMART will be superior to CONT on ability to organize everyday life and ADHD-symptoms, and that vardagsSMART will be superior to selfSMART on adherence, understanding and perecived usefullness.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: VardagsSMART Not Applicable

Detailed Description:

Smartphones have a potential to improve the life of individuals who have major problems with structure and remembrance of everyday tasks. The automation by smartphones of these tasks away from caregivers to the individual is a process that is both time saving and positive for the individuals sense of autonomy.

There is too little research to date to say with clarity that smartphones is this tool for most of the patient group but many patients with ADHD report that a smartphone system for organisation and remembrance is a key that helps many live a more meaningful life.

The best way to teach these skills has not yet been proven. There is a clear advantage with teaching courses concerning IT in an online setting since hyperlinks and other texts can be easily forwarded and the course participants can easily use premade calendars and other tools. This research will try to determine if this type of online course is helpful for these patients.

VardagsSMART is an online course which will be compared to a waiting list controll group (CONT) which weekly records how they manage their ADHD symptoms.

The main purpose of this study is to examine whether the VardagsSMART course have a positive effect for the patient group. An untreated control group is used to ensure that the effects are not only due to spontaneous improvement. The control group will afterwards be offered the course without therapist support (SelfSMART), in order to make a preliminary evaluation of the importance of therapist support.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Online Course for Adults With ADHD or Subclinical ADHD Teaching How to Use a Smartphone as a Support in Their Everyday Life
Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: VardagsSMART
VardagsSMART Internet-based course with therapist support during 6 weeks
Behavioral: VardagsSMART
VardagsSMART Internet-based course with therapist support during 6 weeks
No Intervention: Wait List Control (CONT)
Weekly registrations only. After 6 weeks the Internet-based course without therapist support well be offered (SelfSMART)

Primary Outcome Measures :
  1. Change (from baseline) in symptoms of inattention and concentration [ Time Frame: 6 weeks (Post) and 9 months (FU) ]
    Adult Self Report Scale (ASRS), the subscale measuring inattention and concentration (item 1-4 and 7-11)

Secondary Outcome Measures :
  1. Change (from baseline) in ADHD symptoms [ Time Frame: 6 weeks (Post) and 9 months (FU) ]
    Adult Self Report Scale (ASRS), Full Scale

  2. Change (from baseline) in dialy life function [ Time Frame: 6 weeks (Post) and 9 months (FU) ]
    Sheehan Disability Scale (SDS)

  3. Change (from baseline) in Depression and Anxiety [ Time Frame: 6 weeks (Post) and 9 months (FU) ]
    Hospital Anxiety and Depression Scale (HADS)

  4. Change (from baseline) in perecived stress [ Time Frame: 6 weeks (Post) and 9 months (FU) ]
    Perceived Stress Scale-4 (PSS-4)

Other Outcome Measures:
  1. Treatment evaluation and usage [ Time Frame: Post-treatment (6 weeks) ]
    Questions on treatment satisfaction, adherence, and precevied usefullness of treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • have problems organizing daily activity measured by more then 17 points on the ASRS questionaire item 1-4 and 7-11-
  • has acces to a smartphone (android or iphone) with internet acces.
  • at least 18 years
  • speaks, writes and read Swedish
  • can not foresee any practical barriers to participation.

Exclusion Criteria:

  • has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview.
  • somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders).
  • have severe depression, defined as MADRS-S over 30 or suicidal risk judged by more than 4 points on the MADRS-S question 9 or according to the structured telephone assessment.
  • currently undergoing some form of treatment that focuses on reducing symptoms of ADHD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01663610

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Viktor Kaldo, Ph.D Karolinska Institutet

Responsible Party: Viktor Kaldo, Principal Investigator, Karolinska Institutet Identifier: NCT01663610     History of Changes
Other Study ID Numbers: 2012334314
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014